Clinical Trials /

Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus

NCT02854618

Description:

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
  • Official Title: Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization

Clinical Trial IDs

  • ORG STUDY ID: P/2012/159
  • NCT ID: NCT02854618

Conditions

  • Breast Cancer

Purpose

This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus

Trial Arms

NameTypeDescriptionInterventions
Everolimus treatmentExperimental

    Eligibility Criteria

            Inclusion Criteria:
    
              -  patients eligible for a treatment by everolimus in association with the exemestane
    
              -  Performance status of 0,1 or 2 according to the WHO
    
              -  Patients affected of a breast cancer advanced and\or metastatic HER2 negative
                 expressing the hormonal receptor RH +
    
              -  menopausal Patients
    
            Exclusion Criteria:
    
              -  Psychiatric disease compromising the understanding of the information or the
                 realization of the study
    
              -  Vulnerable people according to the law (minors, adults under protection, private
                 persons of freedom)
    
              -  Histories of cancer in 5 years preceding the diagnosis (except breast cancer,
                 squamous-cell)
    
              -  Not menopausal women
    
              -  Unaffiliated people to the Social Security
    
              -  People being for the period of exclusion from another study
    
              -  Hypersensitivity in the active substance, in the other by-products of the rapamycin or
                 in one of the excipients.
    
              -  Symptomatic visceral achievement
    
              -  Legal incapacity or limited legal capacity
          
    Maximum Eligible Age:85 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:level of the spontaneous anti-telomerase response
    Time Frame:12 months
    Safety Issue:
    Description:evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)

    Secondary Outcome Measures

    Measure:T lymphocytes level
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:everolimus level in serum patients
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:angiopoietin 2 level
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:CD138 level
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:ps6K expression
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Merlin expression
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:neuropilin 2 expression
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:quality of life
    Time Frame:12 months
    Safety Issue:
    Description:EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Centre Hospitalier Universitaire de Besancon

    Last Updated